Quality assurance specialist jobs in Greenwich, CT - 162 jobs

The Quality Registered Nurse plays a vital role in advancing the hospital ' s journey toward the ANCC Pathway to Excellence designation. This position supports the development of a positive practice environment by leading quality improvement initiatives, promoting nursing excellence, and ensuring alignment with the six Pathway Standards: Shared Decision-Making, Leadership, Safety, Quality, Well-Being, and Professional Development. Lead and coordinate quality improvement projects that align with Pathway standards, focusing on patient safety, clinical outcomes, and nursing practice. Support shared governance structures by facilitating nurse-led councils and promoting frontline nurse involvement in decision-making. Monitor and report on nursing-sensitive indicators, including infection rates, falls, medication errors, and readmissions. Conduct audits and root cause analyses to identify opportunities for improvement and ensure compliance with evidence-based practices. Collaborate with nursing leadership to develop and implement strategies that foster a respectful, safe, and empowering work environment. Educate staff on Pathway standards, quality initiatives, and professional development opportunities. Assist in preparing documentation for the Pathway application, including narratives, outcome data, and survey coordination. Promote nurse well-being by supporting initiatives that address physical and mental health, recognition, and work-life balance. How This Role Supports Pathway to Excellence: The Pathway to Excellence designation requires hospitals to demonstrate excellence across six standards: [********************* Shared Decision-Making - Quality Nurses help facilitate nurse-led councils and shared governance. Leadership - They collaborate with nurse leaders to promote transparency, accountability, and mentorship. Safety - They lead initiatives to reduce harm and foster a respectful workplace. Quality - They monitor outcomes and drive continuous improvement. Well-Being - They support programs that promote nurse wellness and recognition. Professional Development - They help create learning opportunities and career advancement pathways. Requirements Bachelor's degree in Nursing (BSN) required, Master's preferred Minimum of 3-5 years of clinical experience in a hospital setting. Experience in quality improvement, patient safety, or nursing excellence programs preferred. Familiarity with ANCC Pathway to Excellence standards and survey process. Strong analytical, communication, and project management skills. Proficiency in data analysis tools and electronic health records. Registered Nurse (RN) with active New York State licensure.

Quality Control Supervisor Our client, a leading biopharmaceutical company, is seeking an experienced Quality Control Supervisor to join their team. This role is responsible for overseeing QC operations in a GMP-regulated environment, ensuring compliance with regulatory standards and internal procedures. Key Responsibilities: Supervise and mentor QC analysts; provide technical guidance and support. Ensure compliance with cGMP, USP, and 21 CFR Parts 210 & 211. Review and approve analytical data, investigations, and CAPAs. Troubleshoot analytical instruments (HPLC, GC, PSD) and support method validation and transfers. Manage testing schedules for raw materials, finished products, stability, and validation samples. Qualifications: BS in a scientific discipline with 5+ years of experience or MS with 3+ years. Hands-on experience with HPLC and Empower software. Strong knowledge of cGMP, USP, and ICH guidelines. Supervisory experience required. This is an excellent opportunity to join a growing organization and make an impact, please apply in directly for more information!

We are seeking an experienced GCP Quality Assurance Auditor to join our rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. This role ensures GXP compliance, drives quality management initiatives, and conducts internal and external audits across clinical trials, safety/pharmacovigilance, and vendor operations (CROs, CMOs, investigator sites). The ideal candidate has extensive GCP experience, a strong pharmaceutical QA background, and expertise in radiopharmaceuticals. This is an on-site position in Northern NJ with flexible hours and minimal domestic travel. Key Responsibilities: Plan and perform global clinical process and vendor audits across all clinical trials Conduct risk-based audits of clinical processes and vendors, including IRT and EDC systems Prepare detailed audit reports and manage related non-conformances Ensure compliance with GCP, FDA, EMA, and ICH regulations Support regulatory inspections and quality improvement initiatives Collaborate with clinical teams, QA, and vendor management Qualifications: Bachelor's degree in a scientific, healthcare, or related discipline 5+ years of pharmaceutical industry experience, including 2+ years in radiopharmaceutical QA Extensive GCP and safety/pharmacovigilance experience Proven experience in internal and external GXP audits Familiarity with QMS, SOPs, clinical systems (IRT, EDC), and regulatory documentation Strong communication and cross-functional collaboration skills Up to 10% domestic travel Why Join Us: Be part of a fast-growing biopharma company making a difference in neurology and psychiatry Hybrid work schedule with flexible hours Opportunity for extension or full-time role

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description Responsibilities: · Provide necessary definition, development and deployment of software quality assurance strategy and roadmap. · Develop and maintain current and comprehensive test plans for Navigators applications. · Act as Subject Matter Expert on the technical aspects, and tools related to testing end to end processes. · Lead and develop the execution of manual and automation test cases and scripts. · Lead and perform various types of testing including functional, regression, performance, user acceptance, etc. · Identify, document and track quality issues through to completion. · Responsible for maintaining up-to-date test plans. · Supervise quality assurance team who may be both internal and external resources and who may be geographically dispersed to ensure the delivery of the QA department goals and objectives · Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment in production environments. · Responsible embedding for QA as part of the SDLC · Meet target deployment schedules. · Measure and evaluate product and QA team performance; recommend improvements. · Identify risks and manage contingencies. · Gather and communicate testing results. · Work with Internal Audit to test and evaluate the design and operating effectiveness of internal controls. Requirements: · Bachelor's Degree or equivalent experience · 7+ years of software testing experience · 4+ years of team leadership · Thorough understanding of formalized QA process and concepts · Proven track record of delivering projects on time and within budget · Experience with Software Development Life Cycle (SDLC) · Strong analytical and problem solving abilities · Additional Information Thanks & Regards Vikas Kumar vikas.kumar(@)360itpro.com

Paramus, NJ (Onsite) | Contract | Mid -Senior Level | 1 Opening Hourly Rate: $60/hour | No Relocation Assistance | No Visa Sponsorship Travel: Up to 10% A growing biopharmaceutical organization is seeking a GCP Quality Assurance Auditor to support global GXP compliance across clinical development, safety/pharmacovigilance, and vendor oversight. This role is ideal for an experienced QA professional with deep GCP expertise and prior experience in Radiopharmaceuticals. This is a 100% onsite role based in Paramus, NJ, supporting a regulated clinical environment. Position Overview The GCP Quality Assurance Auditor will support the GCP/PVG Quality function by planning, executing, and managing internal and external GXP audits. This role partners closely with Clinical Operations, Non -Clinical, Manufacturing, CROs, CMOs, investigator sites, and vendors to ensure compliance with global regulatory requirements and internal quality systems. Key Responsibilities Plan and conduct global clinical process and vendor audits across all clinical trials Perform risk -based audits of clinical systems, processes, and vendors Conduct vendor audits in collaboration with subject matter experts (e.g., IRT, EDC) Develop, finalize, and distribute audit reports to key stakeholders Own and manage audit findings, CAPAs, and non -conformances Audit compliance with GCP, FDA regulations, ICH guidelines, and internal SOPs Partner with Clinical Sourcing, Supplier Quality, and Clinical teams on vendor oversight Support regulatory agency inspections and inspection readiness activities Contribute to continuous quality improvement initiatives RequirementsKey Responsibilities Plan and conduct global clinical process and vendor audits across all clinical trials Perform risk -based audits of clinical systems, processes, and vendors Conduct vendor audits in collaboration with subject matter experts (e.g., IRT, EDC) Develop, finalize, and distribute audit reports to key stakeholders Own and manage audit findings, CAPAs, and non -conformances Audit compliance with GCP, FDA regulations, ICH guidelines, and internal SOPs Partner with Clinical Sourcing, Supplier Quality, and Clinical teams on vendor oversight Support regulatory agency inspections and inspection readiness activities Contribute to continuous quality improvement initiatives Required Qualifications Bachelor's degree in a scientific, healthcare, or related discipline 5+ years of pharmaceutical industry experience 2+ years of experience in Radiopharmaceuticals 2+ years of Quality Assurance experience Extensive hands -on GCP auditing experience Proven experience conducting internal and external GXP audits, including: Clinical Development Safety / Pharmacovigilance Strong working knowledge of FDA, EMA, ICH GCP, and global regulatory requirements Experience auditing clinical systems such as IRT and EDC Familiarity with QMS, SOPs, and compliance documentation Preferred Qualifications Experience supporting regulatory inspections Exposure to global clinical teams and vendors GCP or Quality Auditor certification (preferred, not required) Work Requirements Must be willing and able to work 100% onsite in Paramus, NJ Monday-Friday onsite schedule Up to 10% travel

Certified Group partners with customers to deliver innovative scientific solutions and expertise - So The World Can Trust In What It Consumes. As a leading provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries. We are seeking a highly skilled Quality Assurance Specialist to join our team! In this key role you will work on ensuring compliance with FDA regulations within our industry. The ideal candidate will have extensive experience in managing electronic Quality Management Systems (eQMS), particularly in areas such as Corrective and Preventive Actions (CAPA), Customer Complaints, Out of Specification (OOS) investigations, and conducting Internal Audits. The Quality Assurance Specialist will play a pivotal role in maintaining and improving our quality management processes to uphold the highest standards of product quality and regulatory compliance. Responsibilities: * Assist in the implementation, maintenance, and continuous improvement of the electronic Quality Management System (eQMS) to ensure compliance with FDA regulations. * Lead and coordinate Corrective and Preventive Action (CAPA) processes, including investigation, root cause analysis, implementation of corrective actions, and effectiveness checks. * Handle Customer Complaints and Out of Specification (OOS) investigations, ensuring timely resolution and documentation according to regulatory requirements. * Conduct thorough Internal Audits to assess compliance with established quality procedures, identify areas for improvement, and develop corrective actions as needed. * Collaborate with cross-functional teams to provide quality assurance guidance and support throughout all stages of operation. * Develop and maintain quality-related documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records, equipment maintenance records in accordance with FDA regulations. * Verify that all laboratory instruments and equipment are calibrated and maintained according to established schedules and regulatory standards to ensure accuracy and compliance. Assist in the preparation and hosting of regulatory agency inspections and audits, as well as follow-up activities to address any findings or observations. * Stay abreast of regulatory requirements and industry best practices related to quality assurance and quality management systems and proactively implement necessary changes to ensure compliance. Requirements: * Bachelor's degree in a scientific or technical field, such as Chemistry, Biology, Engineering, or related discipline. * 3-5 years of experience in a quality assurance role within an FDA regulated industry, preferably in pharmaceuticals, medical devices, or biotechnology. * Strong understanding of FDA regulations and guidelines, including cGMP, 21 CFR Part 11, and ICH guidelines. * Proven experience in managing electronic Quality Management Systems (eQMS), such as Qualtrax, Intact, or similar platforms. * Proficiency in conducting investigations, root cause analysis, and implementing corrective actions for CAPA, Customer Complaints, and OOS events. * Experience in conducting Internal Audits and familiarity with audit processes and methodologies. * Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and communicate quality requirements to stakeholders at all levels of the organization. * Strong attention to detail and analytical skills, with the ability to analyze complex data sets and identify trends or areas for improvement. * Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment. BENEFITS: * Progressive 401k Retirement Savings Plan * Employer Paid Short- Term and Long-Term Disability, and Life Insurance * Group Medical * Tuition Reimbursement * Flexible Spending Accounts * Dental * Paid Holidays and Time Off * Many positions which qualify for the company bonus program Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.

The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes. Key Responsibilities: Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers. Prepare detailed audit plans, checklists, and schedules. Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines. Review and approve deviations, CAPAs, and change controls. Document audit observations and issue formal audit reports. Track and verify implementation of corrective and preventive actions (CAPAs). Provide guidance on compliance requirements and audit readiness. Support regulatory inspections and customer audits. Identify systemic issues and recommend process improvements. Stay updated on evolving regulatory requirements and industry best practices. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or related field. 3-5 years in Radio Pharmaceuticals (Must Have), with at least 2 years in auditing. Strong knowledge of RPT cGMP, GDP, and global regulatory requirements. Excellent attention to detail and analytical skills. Strong communication and report-writing abilities. Ability to travel (up to 10%) for audits. Preferred Certifications: ASQ Certified Quality Auditor (CQA) ISO 9001 Lead Auditor GCP/GMP auditing certifications

GCP Quality Assurance Auditor needed for a 6 month on site contract. No visor sponsorship available. 5 years of experience required. Hybrid schedule. Great hourly rate. Skills: GCP, Quality Assurance, RadioPharmaceutical, Radio Pharmaceutical, Pharmaceutical, Audits, Auditor, GXP, Compliance, Quality Management, Clinical Operations, Non-Clinical, Manufacturing, CROs, CMOs, Investigator Sites, Clinical Trials, Audit, Clinical Development, Safety Pharmacovigilance, IRT, EDC, Regulations, FDA, Safety Background, SOPs, QMS QUALIFICATIONS: 5+ years of pharmaceutical experience 2+ years of RadioPharmaceutical and Quality Assurance experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

SourcePro Search is seeking a Quality Assurance Assistant with a Bachelor's Degree in Quality Assurance, Food Science, Biology, Microbiology, Operations Management, or a related field. The ideal candidate will have experience in USDA and FDA food manufacturing, and be bilingual in English and Spanish. The Quality Assurance Assistant is responsible for ensuring that food products meet standards set by both the company and regulatory authorities. The QA Assistant will assist the Director of Food Safety & Compliance to further quality and safety policies and procedures. Must be knowledgeable about food safety standards that are customary within the food industry and mandated by government regulations. The Quality Assurance Assistant is expected to be familiar with the Hazard Analysis and Critical Control Points (HACCP) management system required by the Food and Drug Administration (FDA) and some other standards like SQF or BRC. What You'll Do: ·Perform Daily Product Evaluations and Cook Study Validations. Follow through with the team for corrective actions. ·Understand and implement quality assurance policies and procedures ·Collect and maintain supplier documentation ·Evaluate adequacy of quality assurance standards ·Investigate customer complaints and non-conformance issues ·Collect and compile statistical quality data ·Analyze data to identify areas for improvement in the quality system ·Monitor corrective and preventive actions ·Prepare reports to communicate outcomes of quality activities ·Identify training needs and organize training interventions to meet quality standards ·Monitor risk management activities ·Assure ongoing compliance with quality and industry regulatory requirements What You'll Bring: ·Bachelor's Degree in Quality Assurance, Food Science, Biology, Microbiology, Operations Management or a related field. ·USDA and FDA food manufacturing experience ·Bilingual (Spanish) ·PCQI (Preferred) ·HACCP Certified (Preferred) ·Strong verbal and written English communication skills ·Strong implementation and execution skills ·Good organizational and planning skills ·Ability to be relatable, personable, and productive within a team environment Work Relationships and Scope: ·Reports directly to the Director of Food Safety & Compliance Director. ·Develops good working relationships with the management, co-workers, and other employees. ·Develops working knowledge of the production environment, equipment and can respond to change. ·Develops knowledge of federal, state, and local food safety regulations. Working Conditions: ·This position works in a production environment with the risk of injury. Physical Demands: To successfully perform the essential functions of this role the individual must be able to meet the following requirements, though reasonable accommodation may be made to enable and individual with disabilities. ****************************

*This role is geared toward an entry level candidate (i.e. recent college graduate who possesses 1-3 years of professional work experience) About Harvest Hill: Harvest Hill Beverage Company is one of the nation's largest independent branded beverage producers, delivering consistent annual revenue growth, with sales of over $1 billion. The company was formed in June 2014 with the acquisition of Juicy Juice and further expanded with 3 subsequent acquisitions which were consolidated into one company in May 2017. Our portfolio of iconic brands includes Juicy Juice , SunnyD , Veryfine , Fruit2O , Little HUG , Daily's Cocktails , and Nutrament . We manufacture, market, and distribute across multi-channels including Grocery, Mass Merchandisers, Warehouse Clubs, Convenience, Foodservice, and Liquor Distributors. Harvest Hill is headquartered in Stamford, CT with a nationwide network of manufacturing and distribution facilities, employing over 1,000 employees in the United States. For more information visit harvesthill.com. Position Summary: The QA Coordinator posts files to appropriate internal/external sites and ensures corresponding databases are maintained and up to date. Creates, maintains and ensures all internal HHBC finished product quality documentation is current, accurate and project timelines for the QA team are maintained. The QA Coordinator creates updates & sustains Customer Portal and program documentation; carries out follow-up activities with customers and generates finished product standards as necessary. Directly assist in customer, consumer and field complaint support activities. Primary Position Responsibilities: • Maintain and update internal/external databases (TraceGains/Repositrak/Others) with customer documentation through active engagement in customer portal processes. Generate monthly reports defining completeness, gaps and goals. • Preserve the Harvest Hill customer list identifying products and manufacturing locations with a routine engagement of the gap assessment and resolution activities. • Efficiently coordinate the tracking of consumer, customer and field complaints with weekly reports. • Issue ongoing consumer investigation requests and maintain logs with timeline completion rates. Follow-up with sites on investigations. Support QA Mgr in trends and Complaint rates by categories. • Assists QA Mgr in developing concise feedback on status of field CAPA's and associated timelines. • Supports retrieval of technical details in the development of external and internal technical specifications for finished goods. Meanwhile adhering to HH, FDA, State and Local Regulations and Co-Manufacturing Alliance agreements. • Update and sustain Customer Portal with appropriate program documentation. Ensure through management engagement that customers receive the correct and accurate information. (no more no less). Foster meetings and communication with sales, customer service and QA to ensure accuracy. • Illustrate QA meetings as assigned, document activities and initiate follow-up. • Manage the receipt of new products, trial samples, consumer complaints that are delivered to the CT office. Track and photo packages received, identify location to store and act on disposal as required. Reach out to Sr Director or QA Mgr for direction. • Generate quarterly project timelines for the QA department corporate team. • Analyze & support QA Mgr in recommended next steps as it relates to handling and transportation deficiencies of finished goods. • AX acumen for the HHBC QA team. Within the first 180 days, train on AX, develop tutorials and train all members of our CT staff. • Review all co manufacturer requests for destruction of surplus, expired or defunct finished goods. • As a back-up to cross-functional QA team, learn documentation OOSR, ATS, shelf-life update process. • Support Co-Man and DC Trace exercises which occur a few times a year. • Support product manual upkeep with direct supervision by Head of FSQA. • Additional duties that may be assigned. Position Qualifications: • Candidate should possess a BS/BA degree in science, project management or related field and a minimum preferred of two years of professional career experience. • Proven experience of working with databases, include inputting and extracting data. • Excellent attention to detail with organizational and planning skills. • Ability to self-manage, prioritize and work under pressure to tight deadlines. • Ability to communicate effectively with colleagues, participants and external stakeholders. • Ability to work effectively as part of a team. • Undertake any training and professional development as and when required. • Proficient in Microsoft Office, particularly Access, Word and Excel. Systems experience may include: Microsoft Access, TRACEGAINS, Sharepoint and Red Zone.

Location: Hackensack, NJ Employment Type: Full-time About the Role: We are seeking a detail-oriented and motivated QA Coordinator to join our team. The ideal candidate will be responsible for creating, documenting, and executing system test plans and test scripts, as well as validating data and analyzing test results. This role involves identifying, reporting, and tracking software issues, and communicating findings and progress updates with our software development team in Korea. Key Responsibilities: Develop, document, and execute comprehensive system test plans and test scripts. Perform data validation and analyze test results to ensure software quality. Record, report, track, and retest bugs found during testing. Collaborate and communicate effectively with software developers in Korea to resolve issues. Support continuous improvement of testing processes and documentation. Qualifications: Bachelor's degree in Computer Science or a related field. Bilingual proficiency in Korean and English (both written and verbal). 1-2 years of experience in system testing of Windows-based Point of Sales (POS) software. Hands-on experience with PC POS peripherals such as printers, barcode scanners, customer displays (CDP), and dot matrix printers. Strong analytical, problem-solving, and communication skills. High attention to detail and ability to work in a fast-paced environment. Benefits: Group Health Insurance (Medical, Dental, Vision) Employer paid Life Insurance Paid Sick and Vacation 401K with 3% matching Gym Reimbursement Company Lunch Please visit our website ************* for more information

This role supports production, R&D, and QA by ensuring the accuracy, control, and compliance of all quality-related documents such as batch records, controlled documents, training files, and audit-related documentation within the Quality Management System. Responsibilities:• Create and Issue batch production documentation in alignment with schedule requests.• Review and close production tickets upon completion.• Update the production schedule as needed to reflect workflow changes.• Collaborate with R&D on trial batches and ensure proper documentation.• Perform MBR (Master Batch Record) revisions and manage change control activities.• Updates formulas and master batch record instructions.• Maintain and revise SOPs and OPLs as required.• Distribute updated SOPs/OPLs to appropriate personnel and departments.• Maintain and update the training matrix for the QA department and other functions.• Issues required paperwork for new hire training and orientation.• Support internal audit activities, including collecting documents and preparing files.• File and archive controlled documentation in accordance with document retention policies.• Order and maintain office supplies for the QA department.• Provide general clerical and organizational support to ensure smooth QA operations.• Help maintain a professional and organized workspace.• Perform other tasks as needed. Qualifications:• Must comply with GMP requirements; specific functions will be discussed in GMP and on the job training.• Bachelor's in science preferred. High school diploma or equivalency required.• Strong computer knowledge with Microsoft Office is required.• Project Management skills are required.• Must have excellent verbal, written and interpersonal communication skills.• Must have excellent mathematical.• Must be organized and able to keep records.• Experience in R&D, QA or Production in the Dietary Supplement, Food or Pharmaceutical Industry is a plus.• Experience with FDA, GMP regulated industries a plus. Role's Physical Requirements:• Must be able to lift 50lbs.• Must be able to sit or stand for 8 hours.• Ability to work in a physically challenging environment, including bending, twisting, and standing for up to 8 hours• Work environment - may be exposed to powders, chemicals, and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish, and shellfish) We proudly offer: Medical, Dental, Vision, 401K with Company Match, Pet insurance and more! We reward the hard work of our team members with fun and exciting company events, Summer Picnic, Festive Packages, Holiday Celebrations, and associate referral bonuses! Founded in 2011, Piping Rock Health Products has gone on to win Long Island's Top Workplaces Award 7 years in a row & securing the spot as Top Supplement Manufacturing Company 2024 by Food Business Review! Supported by a group of vitamin visionaries with over 40 years of industry experience and a carefully curated team of talented associates. Piping Rock is a global vitamin and supplement manufacturer with an unwavering commitment to creating quality wellness products. We believe that family always comes first, and that the dedication of our associates is the key ingredient to our success. We are drug free workplace, regulated by the FDA, required to follow Federal Guidelines; therefore in order to start as well as maintain employment, you must be able to successfully clear drug screening processes, which include testing for all illegal substances per Federal Guidelines. Piping Rock Health Products, INC. is an Equal Opportunity Employer.

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title: QA Associate (IT) Employment Type: Full Time - Salaried/Exempt Salary Range: $72,800-$93,600 Work Hours/Shift: 8:30AM - 5:00PM Job Overview: The QA Associate (IT) is responsible for review of batch production records, ensuring that all documentation complies with Good Manufacturing Practices (GMP), regulatory standards, and internal quality assurance procedures. This role ensures the integrity, accuracy, and completeness of batch records related to pharmaceutical manufacturing processes, providing assurance that products are produced according to the approved methods and specifications. Responsibilities: Review batch production records (BPRs), including associated documents (e.g., manufacturing instructions, protocols, and equipment logs), to ensure they are complete, accurate, and compliant with GMP and regulatory guidelines. Verify that all entries are properly documented, signed, and dated by the relevant personnel, and ensure that any discrepancies are resolved before approval. Ensure batch records and associated documentation meet regulatory requirements from agencies such as the FDA, EMA, and other relevant authorities. Review, creation and revision of BPRs, SOPs, and other documents related to manufacturing processes. Ensure batch records are audit-ready and fully compliant for both internal and external audits (e.g., FDA, GMP inspections). Assist audit teams by providing required batch documentation and responding to audit queries related to manufacturing processes and batch records Recommend process improvements to enhance the batch review process, reduce review time, and ensure better compliance. Address any issues or concerns related to batch records raised by cross-functional teams and ensure timely resolution. Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's. Review of engineering records (temperature and humidity data, calibration reports and PMP records). To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing. Other duties [additional support] that management may assign from time to time. Skills: Familiarity with document management systems (e.g., Master Control). Ability to analyze and resolve batch documentation issues in a timely and efficient manner. Experience in preparing for regulatory inspections and audits. Excellent organization skills with the ability to focus on details Strong organizational and time-management skills to handle multiple batch reviews simultaneously. Educational Qualification: Bachelor's degree in pharmacy, Life Sciences, Chemistry, or a related field. Work Experience: Minimum 2-3 years of experience in batch record review or quality assurance in the pharmaceutical industry. Strong knowledge of GMP, regulatory requirements (FDA, EMA), and pharmaceutical manufacturing processes. High attention to detail and accuracy in reviewing complex documentation. Strong communication skills and the ability to collaborate effectively across departments. About Cipla Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose ‘Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States. Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter. About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title: QA Associate (IT) Employment Type: Full Time - Salaried/Exempt Salary Range: $72,800-$93,600 Work Hours/Shift: 8:30AM - 5:00PM Job Overview: The QA Associate (IT) is responsible for review of batch production records, ensuring that all documentation complies with Good Manufacturing Practices (GMP), regulatory standards, and internal quality assurance procedures. This role ensures the integrity, accuracy, and completeness of batch records related to pharmaceutical manufacturing processes, providing assurance that products are produced according to the approved methods and specifications. Responsibilities: * Review batch production records (BPRs), including associated documents (e.g., manufacturing instructions, protocols, and equipment logs), to ensure they are complete, accurate, and compliant with GMP and regulatory guidelines. * Verify that all entries are properly documented, signed, and dated by the relevant personnel, and ensure that any discrepancies are resolved before approval. * Ensure batch records and associated documentation meet regulatory requirements from agencies such as the FDA, EMA, and other relevant authorities. * Review, creation and revision of BPRs, SOPs, and other documents related to manufacturing processes. * Ensure batch records are audit-ready and fully compliant for both internal and external audits (e.g., FDA, GMP inspections). * Assist audit teams by providing required batch documentation and responding to audit queries related to manufacturing processes and batch records * Recommend process improvements to enhance the batch review process, reduce review time, and ensure better compliance. * Address any issues or concerns related to batch records raised by cross-functional teams and ensure timely resolution. * Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's. * Review of engineering records (temperature and humidity data, calibration reports and PMP records). * To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement. * Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing. * Other duties [additional support] that management may assign from time to time. Skills: * Familiarity with document management systems (e.g., Master Control). * Ability to analyze and resolve batch documentation issues in a timely and efficient manner. * Experience in preparing for regulatory inspections and audits. * Excellent organization skills with the ability to focus on details * Strong organizational and time-management skills to handle multiple batch reviews simultaneously. Educational Qualification: Bachelor's degree in pharmacy, Life Sciences, Chemistry, or a related field. Work Experience: * Minimum 2-3 years of experience in batch record review or quality assurance in the pharmaceutical industry. * Strong knowledge of GMP, regulatory requirements (FDA, EMA), and pharmaceutical manufacturing processes. * High attention to detail and accuracy in reviewing complex documentation. * Strong communication skills and the ability to collaborate effectively across departments. About Cipla Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States. Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter. About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.

Job DescriptionDescription: RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing Quality Assurance team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance. Requirements: If this sounds interesting to you, it's probably because up to this point you have: A science degree, specifically in Microbiology. Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency. Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology. Thrived in an environment where growth and change are rapid. Strong Quality Control background preferred. The main responsibilities for this position are: Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies. Revise quality and compliance standard operating procedures as required. Review Quality Control method validation and method transfer protocols/reports. Assist with Internal Audits. Collaborate in management of deviations/CAPAs/change controls. Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance. Assist in the preparation and review of the Annual Product Review. If this sounds like something that is of interest to you, please don't hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.

Full-time Description RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing Quality Assurance team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance. Requirements If this sounds interesting to you, it's probably because up to this point you have: A science degree, specifically in Microbiology. Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency. Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology. Thrived in an environment where growth and change are rapid. Strong Quality Control background preferred. The main responsibilities for this position are: Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies. Revise quality and compliance standard operating procedures as required. Review Quality Control method validation and method transfer protocols/reports. Assist with Internal Audits. Collaborate in management of deviations/CAPAs/change controls. Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance. Assist in the preparation and review of the Annual Product Review. If this sounds like something that is of interest to you, please don't hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc. Salary Description 65,000 -75,000

America Networks is a leading sensor and networking solutions partner for companies in any Industrial, Manufacturing, and Waste management space. We design and manufacture sensors for storage tanks, water metering, energy metering, gas monitoring, and asset management. Our founders are hardcore telecommunications engineers with combined 200 + years of experience in designing, optimizing and performance engineering; for several mid - large wireless carriers internationally - that saw a need to provide low power, cost efficient sensors to collect data, create alerts, and predict needed actions. We have combined these sensors with low power, wide area (LPWA) networking technologies to provide clients various options to decrease re-occurring costs associated with operating an IoT network of sensors and connected devices. We specialize in design, deployment, optimization, and support of these Networks. Whether an off-the-shelf or custom solution is needed, we'll create a solution and push the data on the best cloud platform to fit your needs, including your own. Job Description Plans, directs, and coordinates preparation of project documentation, such as engineering drawings, production specifications and schedules, and contract modifications, to ensure customer contract requirements are met: Reviews contract to determine documentation required for each phase of project, applying knowledge of engineering and manufacturing processes. Schedules due dates for drawings, specifications, software, technical manuals, and other documents. Monitors status of project to ensure documentation is submitted according to schedule. Reviews and verifies project documents for completeness, format, and compliance with contract requirements. Submits project documentation to management for approval, and transmits approved documents to customer. 5 to 7 years of experience. Additional Information Vivek Salvatore vivek.salvatore(@)americanetworks.com **************

The Quality Assurance Associate II (1st Shift, Tuesday-Saturday, 8:00 am- 4:30 pm) is responsible for performing Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, review of QC data, material releases and final product releases as well as assisting Quality management with department needs. Essential Functions and Responsibilities Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture. Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing. Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.) Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing. Release raw material in ERP system as well as on paper. Perform Accessioning of incoming Apheresis. Review Batch record and disposition material of finished product to client. Provides information for Out of Specification and deviations to investigator. Performs line clearance prior to manufacturing operations begins. Other duties as assigned. Knowledge, Skills & Ability Relevant computer skills (Microsoft Office, Outlook) Detail-oriented and organized Analytical and problem-solving skills Good written and oral communication skills Ability to multi-task, prioritize, time manage and be adaptable Flexible and able to adapt to company growth and evolving responsibilities Ability to work independently and with a team Education & Experience BS or higher education degree in a scientifically related field Experience in a biologics or biotechnology company (1 -3 years) Working knowledge and technical understanding of the aseptic manufacture of biologics preferred Working knowledge of GMP and TCTP regulations Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc.) Disclaimer The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

Quality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients Interfaces directly with client and cross functional teams Provides resolutions pertaining to quality for project related issues Independently prioritize, schedule, and manage multiple projects and resources (team) Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements. Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues. Author and review relevant SOPs, validation and other documents. Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports. Responsible for the completion of all client requirements related to cellular product and/or material releases. Master Batch Record Control, distribution and label verification Perform line clearance activities as required. Assignment and maintenance of product Lot numbers as applicable. Perform internal documentation audits as assigned. Materials management nonconformance disposition and release activity as applicable. Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions. Track and trend relevant quality metrics including environmental monitoring data. Provide Quality Assurance related support to various departments. Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies. Electronic Document Control activities as assigned. Provide training to personnel as assigned by supervisor. Travel may be required. REQUIREMENTS BS in biological sciences or other relevant field of study 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics. Working knowledge and technical understanding of aseptic manufacture of biologics Understanding of quality system applications Experience in both clinical and commercial manufacturing is preferred. Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc. Experience in organizing teams for effective and timely completion of projects. Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc. Experience participating in or hosting health authority inspections and/or client audits. Computer skills (Microsoft Office, Outlook) Detail-oriented and organized Analytical and problem-solving skills Good written and oral communication skills Ability to multi-task and be adaptable Flexible and able to adapt to company growth and evolving responsibilities Ability to work independently and with a team Strong Project Management and organization skills Must have the ability to work in a team-oriented environment and with clients Must be able to work during the weekend, holidays and as required by the company May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.